Restor3d has secured clearance from the US Food and Drug Administration (FDA) for its iTotal Identity CR 3DP Porous Total Knee Replacement System, marking the company’s entry into the cementless knee replacement segment.
The 510(k) authorisation allows the orthopaedic technology company to proceed with a limited commercial release of the device in Q3 2025.
The newly approved implant is designed as a fully personalised total knee replacement system and includes cementless femoral, tibial, and patellar components.
Developed using 3D-printed porous technology, the system is intended to support osseointegration and load-bearing capability without requiring cement-based fixation. This product represents the first cementless implant offering in Restor3d’s Identity knee platform.
The system integrates the company’s patient-matched implant design methodology with its proprietary TIDAL Technology. This technology platform features a 3D-printed porous lattice structure, which restor3d has designed to support fatigue resistance and improve bone integration compared to traditional truss-based geometries.
The device includes a pre-navigated surgical system that incorporates personalised instruments and implants supplied in a sterile, single-use kit. This setup is structured to remove intraoperative planning steps and standardise procedural workflows across facilities.
Brian Palumbo from Florida Orthopaedic Institute, Florida said: “The cementless tibial baseplate is designed for optimal stability and fixation, providing maximum coverage without overhang or compromise in rotational alignment. Its strategically placed peripheral pegs enhance stability while avoiding impingement with the tibial cortex, a key factor for long-term implant success.
“Combined with a femoral component that maintains the patient’s native joint mechanics, this system offers a more natural feel and function for patients undergoing knee replacement.”
Restor3d indicated that it plans to collaborate with orthopaedic surgeons throughout the limited release period to monitor surgical outcomes and support the deployment of the cementless platform.
The development follows Restor3d’s acquisition of Conformis, a manufacturer of patient-specific joint replacement implants, which expanded the company’s capabilities in personalised knee systems.
The Identity CR 3DP system is the first new product introduction since the transaction and builds on Restor3d’s strategic direction of integrating 3D printing and digital planning into musculoskeletal reconstruction.
In parallel, Restor3d recently received FDA clearance for the Ossera AFX Ankle Fusion System, another implant based on the company’s TIDAL Technology. The Ossera system is scheduled for commercial launch in May 2025 and is designed to support ankle fusion procedures.
